DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 12th, 2026 has been entered.
Response to Amendment
Claims filed on January 12th, 2026 have been entered. Claims 1-9, 12-13, 21-22, and 24- 30 are pending in the application. The amendment to claim 29 overcomes the previous 35 U.S.C 112(b) rejection.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 24- 26 under 35 U.S.C. 103 over Connor (U.S. 2019/0365472) in view of Friedman et al. (U.S. 2019/0307471) has been withdrawn, specifically Connor ‘472 does not teach a first clamp coupled to a first end of the embolic structure, wherein a distal end of the clamp is rounded.
Claim(s) 1-4, 8- 9, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor (U.S. 2019/0365472) in view of Connor (U.S. 2016/0206321) and in view of Hewitt et al. (WO 2015/160721).
Regarding claim 1, Connor (Connor ‘472) teaches an embolization device comprising: a net, mesh, bag, liner, or stent with a plurality of embolic members or an embolic material inserted into it (Paragraph 0022) (Since the net, mesh, bag, liner, or stent are taught to contain embolic members or materials, they are considered to be embolic structures; As the device of Connor ‘472 comprises embolic material (abstract), it is considered an embolic device wherein the net or mesh is an embolic structure holding the embolic material). The net, mesh, bag, liner or stent are further comprised of braided lattice of wires (Paragraph 0021), are self- expanding (Paragraph 0103), and have a closed distal and proximal end (Paragraph 0103).
Regarding the braided lattice of wires as a matrix configured to allow blood to flow into the plurality of enclosures, as Connor ‘472 teaches that embolic particles can reduce the flow of blood within the aneurysm after blood flows within (Paragraphs 0015), wherein the embolic particles are contained within the net, mesh, bag, liner, or stent (i.e. the braided lattice of wires) within the aneurysm sac (Paragraph 0016), the braided wires of Connor would define a matrix configured to allow blood to flow into the enclosure. In other words, as the device of Connor ‘472 teaches that blood flows into the embolic material to then reduce blood flow, wherein the embolic material is contained within the braided lattice of wires, the lattice of wires must necessarily form a matrix which is configured to allow blood flow.
Regarding the braided lattice of wires in the expanded state as defining a matrix configured to prevent the plurality of embolic particles from escaping, Connor ‘472 is not specific to the claimed limitation. However, as discussed above, Conner ‘472 teaches a method of occluding an aneurysm sac with the use of embolic material by inserting an optimal amount of embolic material or members (see at least Paragraphs 0015, 0037, and 0060). Connor ‘472 further teaches those embolic materials that are less likely to protrude out of the aneurysm can be delivered directly into the aneurysm without the need for a net (Paragraph 0059), such as when they adhere to one another (Paragraphs 0050 and 0051). In other embodiments, however, Connor ‘472 teaches that the optimum amount of embolic material is delivered into a net within the aneurysm (see at least Abstract and Paragraphs 0015, 0016, and 0021). Thus, although Connor ‘472 is not explicit to the claimed limitation, it would have been at least an obvious suggestion of the prior art that the net material hold the embolic particles and prevent them from escaping in order to maintain the optimum amount for occlusion of the aneurysm.
Regarding wherein the embolization device comprises a constrained state and an expanded state, Connor ‘472 teaches that the device can be compressed into a first configuration for delivery (Paragraph 0099) and thus assume a constrained state, Connor ‘472 then teaches that the enclosure can be self-expanding (Paragraph 0103), therefore it can assume an expanded state.
Regarding wherein the self-expanding enclosure is configured to expand solely by self-expansion until the self-expanding enclosure engages with a circumference of a wall of a vessel, the recitation in the claims that the device is “configured to engage solely by self-expansion until the plurality of self-expanding enclosures engage with a circumference of a wall of a vessel” is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim. It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. In this case, as Connor teaches that when the device is inserted into an aneurysm (Paragraph 0103), it self-expands within it, when the device is inserted into a vessel, it would also self-expand in a similar manner. Furthermore, as the device is taught to only expand when within the aneurysm, the device solely self-expands. Therefore, as Connor discloses a self-expanding enclosure, it is clear that the device of Connor would be capable of performing the intended use presently claimed as required in the above cited portion of the MPEP.
Connor ‘472 is silent to an embolic structure comprising a plurality of self- expanding enclosures and a plurality of necked down middle portions wherein at least one necked down middle portion is disposed between each of the plurality of self-expanding enclosures and wherein each of the self-expanding enclosures comprise a braided lattice of wires or a first clamp coupled to a first end of the embolic structure, wherein a distal end of the clamp is rounded.
Connor (Connor ‘321) teaches an embolization device (abstract and Paragraph 0189), comprising: an embolic structure comprising a plurality of self- expanding enclosures (see annotated Fig. 3 below)(Paragraph 0222) and a plurality of necked down middle portions (see annotated Fig. 3 below), wherein at least one necked down middle portion is disposed between each of the plurality of self- expanding enclosures (see annotated Fig. 3 below), and wherein each of the self- expanding enclosures comprise a braided lattice of wires (Paragraph 0195).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the shape of the mesh structure with embolic material as taught by Connor ‘472 to the shape of the mesh structure as taught by Connor ‘321, since Connor ‘321 teaches that the embolic structure “can fill a greater percentage of an aneurysm sac, better reduce blood circulation into the aneurysm sac, and better conform to an irregularly- shaped aneurysm sac than coils or single hollow mesh structures” (Paragraph 0189). Furthermore, one of ordinary skill in the art would have a reasonable expectation of success since Connor ‘472 teaches wherein the embolic material can be inserted into a net, mesh, bag, liner, or stent (abstract), and Connor ‘321 teaches a mesh structure (Paragraph 0225).
In regards to the limitation of each of the plurality of self-expanding enclosures comprises a single, i.e. individual, embolic particle, Connor ‘472 teaches that a plurality of embolic members (i.e. particles; As the embolic members are for treatment of an aneurysm and go within a device that is inserted within an aneurysm of a vessel of the human body (Paragraph 0022), the members are considered to be particles, i.e. tiny or small pieces, as claimed) can be used within the mesh (Paragraph 0022). As the combination of references includes multiple mesh members, it thus would have been obvious for each member to comprise at least a single embolic particle. Furthermore, as Conner ‘472 teaches there is “an optimal volume of embolic material” that depends on the size of the embolic member used (Paragraph 0072) and wherein an optimal range of volumes of embolic material can be “within the range of 85% to 100%” (Paragraph 0069), it would have been further obvious to one of ordinary skill in the art before the effective filing date to have a single embolic particle disposed within each of the plurality of self-expanding enclosures so that the members, i.e. particles would fill 85-100% of the volume. Alternatively, Connor ‘472 sets forth that the size and amount of the embolic particles is a result effective variable, wherein modifying the size and amount of the embolic particles results in safely and effectively occluding an aneurysm (Paragraph 0025). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify the amount of each embolic particles contained within the entire enclosure, and thus also within each corresponding self- expanding enclosure, for the purpose of safely and effectively occluding and filling an aneurysm, since it would only be a matter of optimizing a result effective (MPEP 2144.05). Furthermore, it is noted that the combination of references would result in a braided lattice of wires which defines a matrix configured to allow blood to flow into a plurality of self-expanding enclosures and prevent the embolic particles from escaping.
Regarding wherein the plurality of self-expanding enclosures in the expanded state are aligned along a longitudinal axis of the blood vessel and form a series of planes configured to intersect a direction of blood flow of the vessel when deployed, the recitation in the claims that the device is “aligned along a longitudinal axis of the blood vessel” and “intersecting a direction of blood flow of the vessel when deployed” is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim. It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that the combination discloses an embolic device with a plurality of self-expanding enclosures forming a series of planes and as the planes are aligned along a longitudinal axis (see annotated Fig. 3 of Connor ‘321 below) as presently claimed, it is clear that the embolic device of the combination would be capable of performing the intended use, i.e. intersecting a direction of blood flow of the vessel when deployed and being aligned along a longitudinal axis of the blood vessel, presently claimed as required in the above cited portion of the MPEP.
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The combination of Connor ‘472 and Connor ‘321 does not teach a first clamp coupled to a first end of the embolic structure, wherein a distal end of the clamp is rounded.
Hewitt (Hewitt et al.) teaches a similar device (Figs. 52 and 56)(abstract) comprising an embolic structure (multi- lobe mesh device 2000), with a first end and a second end, comprising a plurality of self- expanding enclosures (proximal lobe 2002, support lobe 2004)(Paragraph 0203) and a necked down middle portion disposed between both of the self- expanding enclosures, wherein the embolic structure is closed on a distal end and a proximal end and a first clamp (distal hub 2010) coupled to a first end of the embolic structure, wherein a distal end of the clamp is rounded (see annotated Fig. 52 below).
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It would have been obvious before the effective filing date to modify the first end of the embolic structure of the combination to have a rounded first clamp coupled to it, since Hewitt teaches that the clamp secures the distal end of the filaments of the structure (Paragraph 0202).
Regarding claims 2 and 4, Connor ‘472, Connor ‘321, and Hewitt make obvious the embolization device as claimed in claim 1.
Connor ‘472 further teaches wherein the plurality of embolic particles (As discussed above, the embolic members in the combination of Connor ‘472 and Connor ‘321 are considered embolic particles since the embolic members are for treatment of an aneurysm and go within a device that is inserted within an aneurysm of a vessel of the human body (Paragraph 0022).) comprise a gelatin material (Paragraph 0083, as Connor ‘472 teaches a gelatinous material and gelatinous means “of or like the protein gelatin” the teachings of Connor ‘472 are considered to encompass or make obvious gelatin.). Since Connor ‘472 teaches the same material as applicant, one would expect the same results, i.e., being bioabsorbable.
Regarding claim 3, Connor ‘472, Connor ‘321, and Hewitt make obvious the embolization device as claimed in claim 1.
Connor ‘472 further wherein the plurality of embolic particles (As discussed above, the embolic members in the combination of Connor ‘472 and Connor ‘321 are considered embolic particles since the embolic members are for treatment of an aneurysm and go within a device that is inserted within an aneurysm of a vessel of the human body (Paragraph 0022)) comprise one or more of collagen and polyvinyl alcohol (Paragraph 0057).
Regarding claim 8, Connor ‘472, Connor ‘321, and Hewitt make obvious the embolization device as claimed in claim 1.
Connor ‘472 further wherein each of the plurality of embolic particles (As discussed above, the embolic members in the combination of Connor ‘472 and Connor ‘321 are considered embolic particles since the embolic members are for treatment of an aneurysm and go within a device that is inserted within an aneurysm of a vessel of the human body (Paragraph 0022)) comprises a thrombogenic agent configured to promote thrombus formation adjacent the embolic particle (Paragraph 0057)(The Examiner takes official notice that Carboxymethyl cellulose was known in the art to be a thrombogenic agent.).
Regarding claim 9, Connor ‘472, Connor ‘321, and Hewitt make obvious the embolization device as claimed in claim 1.
Connor ‘472 further teaches wherein the wires comprise nitinol (Paragraphs 0093- 0094)(Nitinol is known in the art to be a shape- memory material.).
Regarding claim 22, Connor ‘472, Connor ‘321, and Hewitt make obvious the embolization device as claimed in claim 1.
Connor ‘472 wherein each single embolic particle is sized to be contained within the corresponding self- expanding enclosure (Since Connor ‘472 teaches multiple embolic members within a mesh (Paragraph 0022), it would have been obvious that the embolic members are sized to be contained within the corresponding self-expanding enclosure. As stated above, it would have been obvious for the self-expanding enclosure of Connor ‘472 to be made of multiple mesh structures in view of Connor ‘321. Therefore, as the combination results in multiple mesh structures and Connor ‘472 teaches the embolic members within, it would have been obvious for each single embolic particle to be sized to be contained within the corresponding self- expanding enclosure. Furthermore, it is noted that one of ordinary skill in the art would have a reasonable expectation of success as Connor ‘472 teaches that the size of the embolic member can be modified and selected according to the shape of the aneurysm and the volume of the mesh structure (Paragraph 0028). Alternatively, Connor ‘472 sets forth that the size of the embolic particles is a result effective variable, wherein modifying the size of the embolic particles results in safely and effectively occluding an aneurysm (Paragraph 0025). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify the size of each embolic particle to be contained within the corresponding self- expanding enclosure, for the purpose of safely and effectively occluding and filling an aneurysm, since it would only be a matter of optimizing a result effective (MPEP 2144.05).
Claim(s) 5, 7 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor (U.S. 2019/0365472) in view of Connor (U.S. 2016/0206321) and in view of Hewitt et al. (WO 2015/160721) as applied to claim 1 above, in further view of Connor (U.S. 2020/0054344).
Regarding claim 5, Connor ‘472, Connor ‘321, and Hewitt make obvious the embolization device as claimed in claim 1.
Connor ‘472 and Connor ‘321 are silent to wherein each of the plurality of embolic particles includes a defined shape when dry and an amorphous shape when hydrated.
Connor (Connor ‘344) teaches an aneurysm occlusion device comprising a net or mesh with a self-expanding proximal portion and an expandable distal portion; and embolic members which are inserted into the net or mesh (abstract and Paragraph 0041). As the device of Connor ‘344 comprises embolic material, it is considered an embolic device, wherein the net or mesh is an embolic structure holding the embolic material. Connor ‘344 teaches that the proximal portion self-expands, and that in an embodiment the expandable distal portion is also self-expanding (abstract and Paragraphs 0041 and 0052). Thus, encompassing a plurality of self-expanding enclosures.
Connor ‘344 teaches in an example wherein the embolic particles “can swell upon hydration from interaction with blood or other body fluid” (Paragraph 0150)(For the purposes of this examination, the embolic particle is dry when out of the body and hydrated when in the body. Furthermore, since Connor ‘344 teaches that the embolic particles can be defined shapes (Paragraph 0146) and later teaches that the embolic particles, when hydrated “can expand by a factor of 2- 5 times” (Paragraph 0150), Connor ‘344 therefore teaches that each of the plurality of embolic particles include a defined shape when dry and an amorphous shape when hydrated.)(Furthermore, since Connor ‘344 teaches that the embolic particles can be made of a gelatin material (Paragraph 0166), collagen (Paragraph 0176), or polyvinyl alcohol (Paragraph 0163), which is the same material as taught by applicant, one would expect the same results, i.e. an amorphous shape when hydrated.).
Since Connor ‘472, Connor ‘321, and Connor ‘344 teach an embolization device (Connor ‘472, abstract and Paragraph 0022; Connor ‘321, abstract and Paragraph 0189; Connor ‘344, abstract and Paragraph 0041) and Connor ‘472 and Connor ‘344 teach embolic particles of a similar composition (Both Connor ‘472 and Connor ‘344 teach that the embolic particles can be made of a hydrogel or gelatin (Connor ‘472, Paragraphs 0020 and 0057; Connor ‘344, Paragraphs 0163, 0169, and 0176)) disposed within a mesh structure (Connor ‘472, Paragraph 0021; Connor ‘344, Paragraph 0041), it would have been obvious to one of ordinary skill in the art before the effective filing date for the plurality of embolic particles as taught by the combination of Connor ‘472, Connor ‘321, and Hewitt to comprise an amorphous shape when hydrated and a defined shape when dry as taught by Connor ‘344. To use a known form of the disclosed material would have been obvious and well within the purview of one of ordinary skill in the art.
Regarding claim 7, Connor ‘472, Connor ‘321, and Hewitt make obvious the embolization device as claimed in claim 1.
Connor ‘472 and Connor ‘321 are silent to wherein each of the plurality of embolic particles is in a form of a matrix or foam and comprises pores.
Connor ‘344 teaches in a separate embodiment wherein each of the plurality of embolic particles is in a form of a foam (Paragraph 0176) and comprises pores (It is well known in the art that foam would have pores.)(Paragraph 0173).
Since Connor ‘472, Connor ‘321, and Connor ‘344 teach an embolization device (Connor ‘472, abstract and Paragraph 0022; Connor ‘321, abstract and Paragraph 0189; Connor ‘344, abstract and Paragraph 0041) and Connor ‘472 and Connor ‘344 teach embolic particles of a similar composition (Both Connor ‘472 and Connor ‘344 teach that the embolic particles can be made of a hydrogel or gelatin (Connor ‘472, Paragraphs 0020 and 0057; Connor ‘344, Paragraphs 0163, 0169, and 0176)) disposed within a mesh structure (Connor ‘472, Paragraph 0021; Connor ‘344, Paragraph 0041), it would have been obvious to one of ordinary skill in the art before the effective filing date for the plurality of embolic particles as taught by the combination of Connor ‘472, Connor ‘321, and Hewitt to be in the form of a foam and comprise pores as taught by Connor ‘344. To use a known form of the disclosed material would have been obvious and well within the purview of one of ordinary skill in the art.
Regarding claim 21, Connor ‘472, Connor ‘321, Hewitt and Connor ‘344 make obvious the embolization device as claimed in claim 5.
Connor ‘472 and Connor ‘321 are silent to wherein each of the plurality of hydrated embolic particles at least partially return the pre- hydrated defined shape when dried.
Connor ‘344 teaches wherein each of the plurality of hydrated embolic particles at least partially return the pre- hydrated defined shape when dried (Since Connor ‘344 teaches the same material, as discussed above, one would expect similar results, therefore Connor ‘344 teaches this limitation.).
Since Connor ‘472, Connor ‘321, and Connor ‘344 teach an embolization device (Connor ‘472, abstract and Paragraph 0022; Connor ‘321, abstract and Paragraph 0189; Connor ‘344, abstract and Paragraph 0041) and Connor ‘472 and Connor ‘344 teach embolic particles of a similar composition (Both Connor ‘472 and Connor ‘344 teach that the embolic particles can be made of a hydrogel or gelatin (Connor ‘472, Paragraphs 0020 and 0057; Connor ‘344, Paragraphs 0163, 0169, and 0176)) disposed within a mesh structure (Connor ‘472, Paragraph 0021; Connor ‘344, Paragraph 0041), it would have been obvious to one of ordinary skill in the art before the effective filing date for the plurality of embolic particles as taught by the combination of Connor ‘472, Connor ‘321, and Hewitt to at least partially return to the pre- hydrated defined shape when dried as taught by Connor ‘344.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor (U.S. 2019/0365472) in view of Connor (U.S. 2016/0206321) and in view of Hewitt et al. (WO 2015/160721) as applied to claim 1 above, further view of Fitz et al. (WO No. 2012/155093).
Regarding claim 6, Connor ‘472, Connor ‘321, and Hewitt make obvious the embolization device as claimed in claim 1.
Connor ‘472, Connor ‘321, and Hewitt are silent to wherein each of the plurality of embolic particles includes a defined shape when dry and an amorphous shape when hydrated as recited in claim 5, wherein the defined shape is a cylinder as recited in claim 6.
Fitz (Fitz et al.) teaches an embolization device (abstract), comprising: an embolic structure (44)(Fig. 7)(In Paragraph 0044, Fitz teaches that this embolic structure is similar to the embolic structure 14, except it is closed off)(In Paragraph 0006 Fitz teaches a support structure that “secures an expansile plug or embolic material”. Since the support structure contains an embolic material, it is considered to be an embolic structure, due to how it would cause embolization.) comprising a self- expanding enclosure (Paragraph 0026 teaches the framework is expandable; and Paragraph 0027 teaches that the structure can be made of nitinol, which is well known in the art to be a self-expanding material.), wherein the self-expanding enclosure comprises a braided lattice of wires (Paragraph 0027) and an embolic particle (12)(Fig. 7)(According to the Merriam- Webster Dictionary, a particle is defined as “a relatively small or the smallest discrete portion or amount of something”. As the embolic material fits within the frame structure, it is considered to encompass a small amount, or a particle of embolic material as claimed, Fitz therefore teaches an embolic particle.) disposed within the self- expanding enclosure (Paragraphs 0039 and 0044).
Fitz further teaches wherein the embolic particle includes a defined shape (Paragraph 0033) when dry (Paragraph 0033 teaches that the embolic particle is “preferably formed in the shape of a cylinder that expands after being introduced into a patient”. For the purposes of interpretation, the embolic particle is dry when out of the body, and hydrated when in the body.) and an amorphous shape when hydrated (Paragraph 0033 teaches that “In an expanded, unrestricted state (for example, caused by exposure of the plug 12 to water or blood)”, which, for the purpose of this examination, is interpreted as when the embolic particle is hydrated.)(For the purposes of examination, since Fitz teaches the same material as applicant, one would expect the same results, i.e. an amorphous shape when hydrated.).
Fitz further teaches wherein the defined shape is a cylinder (Paragraph 0033).
Since Connor ‘472, Connor ‘321, and Fitz teach an embolization device (Connor ‘472,
abstract and Paragraph 0022; Connor ‘321, abstract and Paragraph 0189; Fitz, abstract and Paragraph Paragraphs 0006 and 0044) and Connor ‘472 and Fitz teach embolic particles of a similar composition (Both Connor ‘472 and Fitz teach that the embolic particles can be made of
a hydrogel or gelatin (Connor ‘472, Paragraphs 0020 and 0057; Fitz, Paragraph 0033)) disposed
within a mesh structure (Connor ‘472, Paragraph 0021; Fitz, Paragraphs 0039 and 0044), it would have been obvious to one of ordinary skill in the art before the effective filing date for the plurality of embolic particles as taught by the combination of Connor ‘472, Connor ‘321, and Hewitt to comprise an amorphous shape when hydrated and a defined shape when dry and a defined shape when dry wherein the defined shape is a cylinder as taught by Fitz. To use a known form of the disclosed material would have been obvious and well within the purview of one of ordinary skill in the art. Furthermore, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the defined shape of the combination of Connor ‘472, Connor ‘321, and Hewitt to be a cylinder as taught by Fitz, since a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976).
Claim(s) 12, 13, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor (U.S. 2019/0365472) in view of Connor (U.S. 2016/0206321) and in view of Hewitt et al. (WO 2015/160721) as applied to claim 1 above, in further view of Qian (U.S. 2009/0112251).
Regarding claims 12 and 13, Connor ‘472, Connor ‘321, and Hewitt make obvious the embolization device as claimed in claim 1.
Connor ‘472, Connor ‘321, and Hewitt do not teach wherein the embolic structure further comprises a threaded clamp coupled to a second end as recited in claim 12, or a placement wire selectively threadingly coupled to the threaded clamp as recited in claim 13.
Qian (Qian et al.) teaches an embolic occlusion device (abstract)(According to the Oxford Dictionary, an embolism is defined as “an obstruction of an artery, typically by a clot of blood or an air bubble”. Qian teaches in Paragraph 0009 that the device can be used to occlude a target site, such as the gonadal vein, which is well known in the art to be an artery. Therefore, the device of Qian obstructs the artery, and is therefore an embolic occlusion device.) that has a self- expanding structure made of nitinol (In Paragraph 0010, Qian teaches that structure is made out of nitinol, which is well known in the art to be a self-expanding material due being a shape- memory material.).
Qian further teaches wherein the embolic structure further comprises a first clamp (82)(Fig. 8) coupled to the first end (Paragraph 0061) and a threaded clamp (87, 88)(Fig. 8) coupled to a second end (Paragraph 0061).
It would be obvious to one of ordinary skill in the art before the effective filing date to modify the device of Connor ‘472, Connor ‘321, and Hewitt to have the threaded clamp as taught by Qian, since Qian teaches that the clamp is used “to avoid fraying” (Paragraph 0060).
Qian also teaches wherein the device further comprises a delivery device (90)(Fig. 8) with a sheath (92, 89)(Fig. 8)(Paragraph 0061) and a placement wire (86)(Fig. 8)(In Paragraph 0061, Qian teaches that the delivery system is a “braided wire” covered in different layers. It is well known in the art that a delivery system would place a device within the body. Therefore, Qian teaches a placement wire.) selectively threadingly coupled to the threaded clamp (In Paragraph 0061, Qian teaches that the delivery system is reversibly connected to the external threads.)(see Fig.8).
It would be obvious to one of ordinary skill in the art before the effective filing date to modify the device of the combination of Connor ‘472, Connor ‘321, and Hewitt to have the clamp and a placement wire selectively threadingly coupled to the threaded clamp as taught by Qian, in order to allow for a reversible connection as taught by Qian (Paragraph 0061).
Regarding claim 30, Connor ‘472, Connor ‘321, and Hewitt make obvious the embolization device as claimed in claim 1.
Connor ‘472, Connor ‘321, and Hewitt do not teach wherein the embolic structure further comprises a threaded clamp coupled to a second end of the embolic structure.
Qian (Qian et al.) teaches an embolic occlusion device (abstract)(According to the Oxford Dictionary, an embolism is defined as “an obstruction of an artery, typically by a clot of blood or an air bubble”. Qian teaches in Paragraph 0009 that the device can be used to occlude a target site, such as the gonadal vein, which is well known in the art to be an artery. Therefore, the device of Qian obstructs the artery, and is therefore an embolic occlusion device.) that has a self- expanding structure made of nitinol (In Paragraph 0010, Qian teaches that structure is made out of nitinol, which is well known in the art to be a self-expanding material due being a shape- memory material.). Qian further teaches wherein the embolic structure further comprises a first clamp (82)(Fig. 8) coupled to the first end (Paragraph 0061) and a threaded clamp (87, 88)(Fig. 8) coupled to a second end (Paragraph 0061).
It would be obvious to one of ordinary skill in the art before the effective filing date to modify the device of Connor ‘472, Connor ‘321, and Hewitt to have the threaded clamp as taught by Qian, since Qian teaches that the clamp is used “to avoid fraying” (Paragraph 0060).
Regarding wherein the embolic structure extends continuously from the first clamp coupled to the first end of the embolic structure to a threaded clamp coupled to a second end of the embolic structure, as Connor ‘321 teaches a structure that extends continuously from a proximal end to a distal end (see annotated Fig. 3 below), and the combination has a first clamp coupled to the first end of the embolic structure (Hewitt, distal hub 2010) to a threaded clamp coupled to a second end of the embolic structure (Quan, 87, 88)(Paragraph 0061), then the structure of the combination would extend continuously from the first clamp to the threaded clamp.
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Claim(s) 24- 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor (U.S. 2019/0365472) in view of Friedman et al. (U.S. 2019/0307471), and in view of Hewitt et al. (WO 2015/160721).
Regarding claim 24, Connor (Connor ‘472) teaches an embolization device comprising: a net, mesh, bag, liner, or stent with a plurality of embolic members or an embolic material inserted into it (Paragraph 0022) (Since the net, mesh, bag, liner, or stent are taught to contain embolic members or materials, they are considered to be embolic structures; As the device of Connor ‘472 comprises embolic material (abstract), it is considered an embolic device wherein the net or mesh is an embolic structure holding the embolic material). The net, mesh, bag, liner or stent are further comprised of braided lattice of wires (Paragraph 0021), are self- expanding (Paragraph 0103), and have a closed distal and proximal end (Paragraph 0103).
Regarding the braided lattice of wires as a matrix configured to allow blood to flow into the plurality of enclosures, as Connor ‘472 teaches that embolic particles can reduce the flow of blood within the aneurysm after blood flows within (Paragraphs 0015), wherein the embolic particles are contained within the net, mesh, bag, liner, or stent (i.e. the braided lattice of wires) within the aneurysm sac (Paragraph 0016), the braided wires of Connor would define a matrix configured to allow blood to flow into the enclosure. In other words, as the device of Connor ‘472 teaches that blood flows into the embolic material to then reduce blood flow, wherein the embolic material is contained within the braided lattice of wires, the lattice of wires must necessarily form a matrix which is configured to allow blood flow.
Regarding the braided lattice of wires in the expanded state as defining a matrix configured to prevent the plurality of embolic particles from escaping, Connor ‘472 is not specific to the claimed limitation. (this is important to establish it is not there). However, as discussed above, Conner ‘472 teaches a method of occluding an aneurysm sac with the use of embolic material by inserting an optimal amount of embolic material or members (see at least Paragraphs 0015, 0037, and 0060). Connor ‘472 further teaches those embolic materials that are less likely to protrude out of the aneurysm can be delivered directly into the aneurysm without the need for a net (Paragraph 0059), such as when they adhere to one another (Paragraphs 0050 and 0051). In other embodiments, however, Connor ‘472 teaches that the optimum amount of embolic material is delivered into a net within the aneurysm (see at least Abstract and Paragraphs 0015, 0016, and 0021). Thus, although Connor ‘472 is not explicit to the claimed limitation, it would have been at least an obvious suggestion of the prior art that the net material hold the embolic particles and prevent them from escaping in order to maintain the optimum amount for occlusion of the aneurysm.
Regarding wherein the embolization device comprises a constrained state and an expanded state, Connor ‘472 teaches that the device can be compressed into a first configuration for delivery (Paragraph 0099) and thus assume a constrained state, Connor ‘472 then teaches that the enclosure can be self-expanding (Paragraph 0103), therefore it can assume an expanded state.
Regarding wherein the self-expanding enclosure is configured to expand solely by self-expansion until the self-expanding enclosure engages with a circumference of a wall of a vessel, the recitation in the claims that the device is “configured to engage solely by self-expansion until the plurality of self-expanding enclosures engage with a circumference of a wall of a vessel” is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim. It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. In this case, as Connor teaches that when the device is inserted into an aneurysm (Paragraph 0103), it self-expands within it, when the device is inserted into a vessel, it would also self-expand in a similar manner. Furthermore, as the device is taught to only expand when within the aneurysm, the device solely self-expands. Therefore, as Connor discloses a self-expanding enclosure, it is clear that the device of Connor would be capable of performing the intended use presently claimed as required in the above cited portion of the MPEP.
Connor ‘472 is silent to an embolic structure comprising a plurality of self- expanding enclosures and a plurality of necked down middle portions wherein at least one necked down middle portion is disposed between each of the plurality of self-expanding enclosures and wherein each of the self-expanding enclosures comprise a braided lattice of wires or wherein each of the at least one necked down middle portions in the expanded state comprises a passageway between the adjacent self- expanding enclosures that prevents the embolic particles from passing from one self- expanding enclosure to an adjacent self-expanding enclosure.
Friedman (Friedman et al.) teaches a device (Fig. 23A- 23B) for use in a vessel () comprising: a structure (intraluminal device 20000) comprising a plurality of self- expanding enclosures (23400, 23600, 23602, 23604)(Paragraph 0094- 0097) and a plurality of necked down middle portions (Paragraph 0096), wherein at least one necked down middle portion is disposed between each of the plurality of self-expanding enclosures, and wherein each of the at least one necked down middle portions in the expanded state comprises a passageway between the adjacent self- expanding enclosures (see annotated Fig. 23B below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the shape of the embolic structure to have the shape of the structure as taught by Friedman, as one of ordinary skill in the art would have a reasonable expectation of success since Connor ‘472 teaches wherein the embolic material can be inserted into a net, mesh, bag, liner, or stent (abstract), and Friedman teaches a mesh structure (Paragraph 0094).
In regards to the limitation of each of the plurality of self-expanding enclosures comprises a single, i.e. individual, embolic particle and wherein the passageway prevents the embolic particles from passing from one self- expanding enclosure to an adjacent self-expanding enclosure, Connor ‘472 teaches that a plurality of embolic members (i.e. particles; As the embolic members are for treatment of an aneurysm and go within a device that is inserted within an aneurysm of a vessel of the human body (Paragraph 0022), the members are considered to be particles, i.e. tiny or small pieces, as claimed) can be used within the mesh (Paragraph 0022). As the combination of references includes multiple mesh members, it thus would have been obvious for each member to comprise at least a single embolic particle. Furthermore, as Conner ‘472 teaches there is “an optimal volume of embolic material” that depends on the size of the embolic member used (Paragraph 0072) and wherein an optimal range of volumes of embolic material can be “within the range of 85% to 100%” (Paragraph 0069), it would have been further obvious to one of ordinary skill in the art before the effective filing date to have a single embolic particle disposed within each of the plurality of self-expanding enclosures so that the members, i.e. particles would fill 85-100% of the volume. Alternatively, Connor ‘472 sets forth that the size and amount of the embolic particles is a result effective variable, wherein modifying the size and amount of the embolic particles results in safely and effectively occluding an aneurysm (Paragraph 0025). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify the amount of each embolic particles contained within the entire enclosure, and thus also within each corresponding self- expanding enclosure, for the purpose of safely and effectively occluding and filling an aneurysm, since it would only be a matter of optimizing a result effective (MPEP 2144.05). Furthermore, it is noted that the combination of references would result in a braided lattice of wires which defines a matrix configured to allow blood to flow into a plurality of self-expanding enclosures and prevent the embolic particles from escaping. With the embolic material sized for each self- expanding enclosure, the embolic material would not be able to pass through the passageway of the device as it would not fit.
The combination of Connor ‘472 and Friedman does not teach a first clamp coupled to a first end of the embolic structure, wherein a distal end of the clamp is rounded.
Hewitt (Hewitt et al.) teaches a similar device (Figs. 52 and 56)(abstract) comprising an embolic structure (multi- lobe mesh device 2000), with a first end and a second end, comprising a plurality of self- expanding enclosures (proximal lobe 2002, support lobe 2004)(Paragraph 0203) and a necked down middle portion disposed between both of the self- expanding enclosures, wherein the embolic structure is closed on a distal end and a proximal end and a first clamp (distal hub 2010) coupled to a first end of the embolic structure, wherein a distal end of the clamp is rounded (see annotated Fig. 52 below).
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It would have been obvious before the effective filing date to modify the first end of the embolic structure of the combination to have a rounded first clamp coupled to it, since Hewitt teaches that the clamp secures the distal end of the filaments of the structure (Paragraph 0202).
Regarding claim 25, Connor ‘472, Friedman, and Hewitt make obvious the embolization device as claimed in claim 24.
Connor ‘472 further teaches wherein the wires comprise nitinol (Paragraphs 0093- 0094)(Nitinol is known in the art to be a shape- memory material.).
Regarding claim 26, Connor ‘472, Friedman, and Hewitt make obvious the embolization device as claimed in claim 24.
Connor ‘472 wherein each single embolic particle is sized to be contained within the corresponding self- expanding enclosure (Since Connor ‘472 teaches multiple embolic members within a mesh (Paragraph 0022), it would have been obvious that the embolic members are sized to be contained within the corresponding self-expanding enclosure. As stated above, it would have been obvious for the self-expanding enclosure of Connor ‘472 to be made of multiple mesh structures in view of Connor ‘321. Therefore, as the combination results in multiple mesh structures and Connor ‘472 teaches the embolic members within, it would have been obvious for each single embolic particle to be sized to be contained within the corresponding self- expanding enclosure. Furthermore, it is noted that one of ordinary skill in the art would have a reasonable expectation of success as Connor ‘472 teaches that the size of the embolic member can be modified and selected according to the shape of the aneurysm and the volume of the mesh structure (Paragraph 0028). Alternatively, Connor ‘472 sets forth that the size of the embolic particles is a result effective variable, wherein modifying the size of the embolic particles results in safely and effectively occluding an aneurysm (Paragraph 0025). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify the size of each embolic particle to be contained within the corresponding self- expanding enclosure, for the purpose of safely and effectively occluding and filling an aneurysm, since it would only be a matter of optimizing a result effective (MPEP 2144.05).
Regarding claim 27, Connor (Connor ‘472) teaches an embolization device comprising: a net, mesh, bag, liner, or stent with a plurality of embolic members or an embolic material inserted into it (Paragraph 0022) (Since the net, mesh, bag, liner, or stent are taught to contain embolic members or materials, they are considered to be embolic structures; As the device of Connor ‘472 comprises embolic material (abstract), it is considered an embolic device wherein the net or mesh is an embolic structure holding the embolic material). The net, mesh, bag, liner or stent are further comprised of braided lattice of wires (Paragraph 0021), are self- expanding (Paragraph 0103), and have a closed distal and proximal end (Paragraph 0103).
Regarding the braided lattice of wires as a matrix configured to allow blood to flow into the plurality of enclosures, as Connor ‘472 teaches that embolic particles can reduce the flow of blood within the aneurysm after blood flows within (Paragraphs 0015), wherein the embolic particles are contained within the net, mesh, bag, liner, or stent (i.e. the braided lattice of wires) within the aneurysm sac (Paragraph 0016), the braided wires of Connor would define a matrix configured to allow blood to flow into the enclosure. In other words, as the device of Connor ‘472 teaches that blood flows into the embolic material to then reduce blood flow, wherein the embolic material is contained within the braided lattice of wires, the lattice of wires must necessarily form a matrix which is configured to allow blood flow.
Regarding the braided lattice of wires in the expanded state as defining a matrix configured to prevent the plurality of embolic particles from escaping, Connor ‘472 is not specific to the claimed limitation. (this is important to establish it is not there). However, as discussed above, Conner ‘472 teaches a method of occluding an aneurysm sac with the use of embolic material by inserting an optimal amount of embolic material or members (see at least Paragraphs 0015, 0037, and 0060). Connor ‘472 further teaches those embolic materials that are less likely to protrude out of the aneurysm can be delivered directly into the aneurysm without the need for a net (Paragraph 0059), such as when they adhere to one another (Paragraphs 0050 and 0051). In other embodiments, however, Connor ‘472 teaches that the optimum amount of embolic material is delivered into a net within the aneurysm (see at least Abstract and Paragraphs 0015, 0016, and 0021). Thus, although Connor ‘472 is not explicit to the claimed limitation, it would have been at least an obvious suggestion of the prior art that the net material hold the embolic particles and prevent them from escaping in order to maintain the optimum amount for occlusion of the aneurysm.
Regarding wherein the embolization device comprises a constrained state and an expanded state, Connor ‘472 teaches that the device can be compressed into a first configuration for delivery (Paragraph 0099) and thus assume a constrained state, Connor ‘472 then teaches that the enclosure can be self-expanding (Paragraph 0103), therefore it can assume an expanded state.
Connor ‘472 is silent to an embolic structure comprising a plurality of self- expanding enclosures and a plurality of necked down middle portions wherein at least one necked down middle portion is disposed between each of the plurality of self-expanding enclosures and wherein each of the self-expanding enclosures comprise a braided lattice of wires, wherein each of the at least one necked down middle portions in the expanded state comprises a passageway between the adjacent self- expanding enclosures that prevents the embolic particles from passing from one self- expanding enclosure to an adjacent self-expanding enclosure or a first clamp coupled to a first end of the embolic structure, wherein a distal end of the clamp is rounded.
Friedman (Friedman et al.) teaches a device (Fig. 23A- 23B) for use in a vessel () comprising: a structure (intraluminal device 20000) comprising a plurality of self- expanding enclosures (23400, 23600, 23602, 23604)(Paragraph 0094- 0097) and a plurality of necked down middle portions (Paragraph 0096), wherein at least one necked down middle portion is disposed between each of the plurality of self-expanding enclosures, and wherein each of the at least one necked down middle portions in the expanded state comprises a passageway between the adjacent self- expanding enclosures (see annotated Fig. 23B below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the shape of the embolic structure to have the shape of the structure as taught by Friedman, as one of ordinary skill in the art would have a reasonable expectation of success since Connor ‘472 teaches wherein the embolic material can be inserted into a net, mesh, bag, liner, or stent (abstract), and Friedman teaches a mesh structure (Paragraph 0094).
The combination of Connor ‘472 and Friedman does not teach a first clamp coupled to a first end of the embolic structure, wherein a distal end of the clamp is rounded.
Hewitt (Hewitt et al.) teaches a similar device (Figs. 52 and 56)(abstract) comprising an embolic structure (multi- lobe mesh device 2000), with a first end and a second end, comprising a plurality of self- expanding enclosures (proximal lobe 2002, support lobe 2004)(Paragraph 0203) and a necked down middle portion disposed between both of the self- expanding enclosures, wherein the embolic structure is closed on a distal end and a proximal end and a first clamp (distal hub 2010) coupled to a first end of the embolic structure, wherein a distal end of the clamp is rounded (see annotated Fig. 52 below).
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It would have been obvious before the effective filing date to modify the first end of the embolic structure of the combination to have a rounded first clamp coupled to it, since Hewitt teaches that the clamp secures the distal end of the filaments of the structure (Paragraph 0202).
In regards to the limitation of each of the plurality of self-expanding enclosures comprises a single, i.e. individual, embolic particle and wherein the passageway prevents the embolic particles from passing from one self- expanding enclosure to an adjacent self-expanding enclosure, Connor ‘472 teaches that a plurality of embolic members (i.e. particles; As the embolic members are for treatment of an aneurysm and go within a device that is inserted within an aneurysm of a vessel of the human body (Paragraph 0022), the members are considered to be particles, i.e. tiny or small pieces, as claimed) can be used within the mesh (Paragraph 0022). As the combination of references includes multiple mesh members, it thus would have been obvious for each member to comprise at least a single embolic particle. Furthermore, as Conner ‘472 teaches there is “an optimal volume of embolic material” that depends on the size of the embolic member used (Paragraph 0072) and wherein an optimal range of volumes of embolic material can be “within the range of 85% to 100%” (Paragraph 0069), it would have been further obvious to one of ordinary skill in the art before the effective filing date to have a single embolic particle disposed within each of the plurality of self-expanding enclosures so that the members, i.e. particles would fill 85-100% of the volume. Alternatively, Connor ‘472 sets forth that the size and amount of the embolic particles is a result effective variable, wherein modifying the size and amount of the embolic particles results in safely and effectively occluding an aneurysm (Paragraph 0025). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify the amount of each embolic particles contained within the entire enclosure, and thus also within each corresponding self- expanding enclosure, for the purpose of safely and effectively occluding and filling an aneurysm, since it would only be a matter of optimizing a result effective (MPEP 2144.05). Furthermore, it is noted that the combination of references would result in a braided lattice of wires which defines a matrix configured to allow blood to flow into a plurality of self-expanding enclosures and prevent the embolic particles from escaping. With the embolic material sized for each self- expanding enclosure, the embolic material would not be able to pass through the passageway of the device as it would not fit.
Regarding wherein the plurality of self-expanding enclosures in the expanded state are aligned along a longitudinal axis of the blood vessel and form a series of planes configured to intersect a direction of blood flow of the vessel when deployed, the recitation in the claims that the device is “aligned along a longitudinal axis of the blood vessel” and “intersecting a direction of blood flow of the vessel when deployed” is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim. It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that the combination discloses a device with a plurality of self-expanding enclosures forming a series of planes and aligned along a longitudinal axis (see annotated Fig. 23B of Friedman below) as presently claimed, it is clear that the embolic device of the combination would be capable of performing the intended use, i.e. intersecting a direction of blood flow of the vessel and being aligned along a longitudinal axis of the blood vessel when deployed, presently claimed as required in the above cited portion of the MPEP.
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Regarding claim 28, Connor ‘472, Friedman, and Hewitt make obvious the embolization device as claimed in claim 27.
Connor ‘472 further teaches wherein the plurality of embolic particles (As discussed above, the embolic members in the combination of Connor ‘472 and Friedman are considered embolic particles since the embolic members are for treatment of an aneurysm and go within a device that is inserted within an aneurysm of a vessel of the human body (Connor ‘472, Paragraph 0022).) comprise a gelatin material (Paragraph 0083, as Connor ‘472 teaches a gelatinous material and gelatinous means “of or like the protein gelatin” the teachings of Connor ‘472 are considered to encompass or make obvious gelatin.). Since Connor ‘472 teaches the same material as applicant, one would expect the same results, i.e., being bioabsorbable.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor (U.S. 2019/0365472) in view of Connor (U.S. 2016/0206321) in view of Hewitt et al. (WO 2015/160721), and in view of Friedman et al. (US 2019/0307471), as applied to claim 27 above, in further view of Qian (U.S. 2009/0112251).
Regarding claim 29, Connor ‘472 and Connor ‘321 make obvious the embolization device as claimed in claim 27.
Connor ‘472, Friedman, and Hewitt do not teach wherein the embolic structure further comprises a threaded clamp coupled to a second end, or a placement wire selectively threadingly coupled to the threaded clamp.
Qian (Qian et al.) teaches an embolic occlusion device (abstract)(According to the Oxford Dictionary, an embolism is defined as “an obstruction of an artery, typically by a clot of blood or an air bubble”. Qian teaches in Paragraph 0009 that the device can be used to occlude a target site, such as the gonadal vein, which is well known in the art to be an artery. Therefore, the device of Qian obstructs the artery, and is therefore an embolic occlusion device.) that has a self- expanding structure made of nitinol (In Paragraph 0010, Qian teaches that structure is made out of nitinol, which is well known in the art to be a self-expanding material due being a shape- memory material.).
Qian further teaches wherein the embolic structure further comprises a first clamp (82)(Fig. 8) coupled to the first end (Paragraph 0061) and a threaded clamp (87, 88)(Fig. 8) coupled to a second end (Paragraph 0061).
It would be obvious to one of ordinary skill in the art before the effective filing date to modify the device of Connor, Friedman and Hewitt to have the threaded clamp as taught by Qian, since Qian teaches that the clamps are used “to avoid fraying” (Paragraph 0060).
Qian also teaches wherein the device further comprises a delivery device (90)(Fig. 8) with a sheath (92, 89)(Fig. 8)(Paragraph 0061) and a placement wire (86)(Fig. 8)(In Paragraph 0061, Qian teaches that the delivery system is a “braided wire” covered in different layers. It is well known in the art that a delivery system would place a device within the body. Therefore, Qian teaches a placement wire.) selectively threadingly coupled to the threaded clamp (In Paragraph 0061, Qian teaches that the delivery system is reversibly connected to the external threads.)(see Fig.8).
It would be obvious to one of ordinary skill in the art before the effective filing date to modify the device of the combination of Connor ‘472, Friedman and Hewitt to have the threaded clamp and a placement wire selectively threadingly coupled to the threaded clamp as taught by Qian, in order to allow for a reversible connection as taught by Qian (Paragraph 0061).
Response to Arguments
Applicant's arguments filed January 12th, 2026 have been fully considered but they are not persuasive.
Applicant’s argument, see Page 11, regarding that the references do not teach or suggest that, in the expanded state, the plurality of self- expanding enclosures are aligned along a longitudinal axis of a blood vessel has been fully considered but is not persuasive. As discussed above, the recitation in the claims that the device is “aligned along a longitudinal axis of the blood vessel” is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim. It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that the combination discloses an embolic device with a plurality of self-expanding enclosures forming a series of planes and as the planes are aligned along a longitudinal axis (see annotated Fig. 3 of Connor ‘321 below) as presently claimed, it is clear that the embolic device of the combination would be capable of performing the intended use, i.e. being aligned along a longitudinal axis of the blood vessel, presently claimed as required in the above cited portion of the MPEP.
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Applicant’s argument, see Page 11, regarding that the cited references fail to disclose or suggest that the plurality of self- expanding enclosures, in the expanded state, form a series of planes configured to intersect a direction of blood flow of a vessel when deployed has been fully considered but is not persuasive. As discussed above, the recitation in the claims that the device is “aligned along a longitudinal axis of the blood vessel” is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim. It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that the combination discloses an embolic device with a plurality of self-expanding enclosures forming a series of planes and as the planes are aligned along a longitudinal axis (see annotated Fig. 3 of Connor ‘321 below) as presently claimed, it is clear that the embolic device of the combination would be capable of performing the intended use, i.e. intersecting a direction of blood flow of the vessel when deployed and being aligned along a longitudinal axis of the blood vessel, presently claimed as required in the above cited portion of the MPEP.
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Applicant’s argument, see Page 11, that Hewitt is incompatible with Connor -472 and Connor ‘321 has been fully considered but is not persuasive. Hewitt is relied upon within the rejection for the idea of a clamp at a first end, not for the embolic structure. Furthermore Connor ‘472, Connor ‘321, and Hewitt all teach embolic structures for positioning within the body (Connor ‘472, Paragraph 0022; Connor ‘321, Paragraph 0189; Hewitt, Paragraph 0203), and it would have been obvious before the effective filing date to modify the first end of the embolic structure of the combination to have a rounded first clamp coupled to it, since Hewitt teaches that the clamp secures the distal end of the filaments of the structure (Paragraph 0202).
Applicant’s argument, see Page 12, that none of the cited reference discloses or suggests that the embolic structure extends continuously from the first clamp coupled to the first end of the embolic structure to a threaded clamp coupled to a second end of the embolic structure has been fully considered but is not persuasive. As discussed above, as Connor ‘321 teaches a structure that extends continuously from a proximal end to a distal end (see annotated Fig. 3 below), and the combination has a first clamp coupled to the first end of the embolic structure (Hewitt, distal hub 2010) to a threaded clamp coupled to a second end of the embolic structure (Quan, 87, 88)(Paragraph 0061), then the structure of the combination would extend continuously from the first clamp to the threaded clamp.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771